(94 days)
No
The summary describes a quality control material for urine chemistry analysis and does not mention any AI/ML components or capabilities.
No
Explanation: The device is an assayed QC material for monitoring urine chemistry analytes and devices. It is for in vitro diagnostic use and simulates human urine. It is not used to treat or cure a disease.
No
This device is an assayed QC material used for monitoring urine chemistry analytes and devices. It is explicitly for "in vitro diagnostic (IVD) use only," which means it's used to test samples from the body, but it doesn't itself diagnose a condition in a patient. It helps ensure the accuracy of other diagnostic devices.
No
The device description clearly states it is a physical material (synthetic matrix simulating human urine with biological components) used as a control for urine chemistry analyzers and strips, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic (IVD) use only."
N/A
Intended Use / Indications for Use
IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Product codes
JJW
Device Description
The proposed IRISpec™ CA/CB/CC Control is identical in its parts A and B to the unmodified IRISpec Urine Chemistry Control part A and Part B control currently in commercial distribution (K945913). The only difference between the predicate device and the proposed CA/CB/CC Urinalysis Control is that the new product has a claim for ascorbic acid in part C and the predicate device does not have a claim for ascorbic acid nor a part C. The matrix for part C is identical to that of part B so that part B is the negative control for ascorbic acid.
IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.
The following reagents are used in new CC: L-Ascorbic Acid
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Stability:
Closed vial stability of proposed CC controls was verified in real time on samples from three lots stored at 2-8°C, compared to reference samples stored at -20°C. The semi-quantitative variable used as a measure of stability was concentration as measured by an iChem 100 Urine Chemistry Analyzer and iChem 10SG urine chemistry strips. The criterion for meeting the stability claim was no more than one grade change in concentration over a six month period. Samples were tested at the following time points: 1 months, 3 months, 4 months, 6 months, and 7 months. All vials tested had recoveries of 40mg/dL ascorbic acid for all three lots of IRISpec™CC controls after 7 months of real time stability. All negative controls (IRISpec™CA and IRISpec™ CB) tested NEG for ascorbic acid after 7 months of real time stability.
Accelerated Temperature Stability Studies:
Triplicate samples of all three lots of the IRISpec™CC controls were stored at accelerated temperatures of 25° C for 20 days, 16 days, 10 days and 3 days. Triplicate samples of all three lots of IRISpec™CC controls were stored at accelerated temperatures of 35° C for 7 days, 6 days, 3 days, and 1 day. All samples provided ascorbic acid values of 40 mg/dL during the entire length of the study at each temperature. Additionally, triplicate samples for all three IRISpec™ CC lots and IRISpec™ CA and IRISpec ™CB were incubated at 25°C for 6 months. All IRISpec™ CC samples provided ascorbic acid values of 40mg/dL. All IRISpec™CA and CB controls were NEG for ascorbic acid, as expected.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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DEC 2 1 2007
510(k) Summary
Summary Date:
25 October, 2007
Applicant:
Iris Diagnostics, a Division of IRIS International Inc 9172 Eton Avenue Chatsworth, CA 91311 (818) 709-1244 Gerald J. Haddock, P.E. RAC, Director, Quality Assurance and Regulatory Affairs
Proprietary and Established Names:
Proprietary name: IRISpec™ CA/CB/CC
Classification name: Quality control material (assayed and unassayed).
Common name: Urinalysis controls
Device to which substantial equivalence is claimed
IRISpec Urine Chemistry Control Part A and B. Iris Diagnostics, a Division of IRIS International, Inc. Chatsworth, CA 91311
File No. K945913
Description of the proposed device:
The proposed IRISpec™ CA/CB/CC Control is identical in its parts A and B to the unmodified IRISpec Urine Chemistry Control part A and Part B control currently in commercial distribution (K945913). The only difference between the predicate device and the proposed CA/CB/CC Urinalysis Control is that the new product has a claim for ascorbic acid in part C and the predicate device does not have a claim for ascorbic acid nor a part C. The matrix for part C is identical to that of part B so that part B is the negative control for ascorbic acid.
Intended Use:
IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert.
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Comparison of the proposed device with the predicate device
| Device | IRISpec™ CA/CB/CC
(Proposed Device) | IRISpec Urine Chemistry Control, parts A and B
(Predicate Device) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Composition | CA and CB are identical to parts A and B of predicate device. Matrix for CC is identical to that of CB | Synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, and bilirubin. No human sourced materials. |
| Form | Same as predicate | Liquid, ready to use |
| Packaging-container | Same as predicate | Glass bottle with plastic screw cap |
| Packaging-fill volume | Same as predicate | 100 mL |
| Preservatives | Same as predicate | 0.0048% gluteraldehyde |
| Storage | Same as predicate | 2° to 8° C
Until expiration date |
| Stability-closed vial | Same as predicate | 6 months at 2° to 8° C |
| Stability-open vial | Same as predicate | 15 days at 2° to 8° C |
| Differences | | |
| Intended use | IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. | The IRISpec Urine Chemistry Controls are intended to be used as a quality control material for all CHEMSTRIP™ urine reagent strips |
| Analytes | Same as predicate device except for addition of ascorbic acid in CC | Specific Gravity, pH, Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocytes |
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Device Description
IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.
The following reagents are used in new CC:
L-Ascorbic Acid
Physical properties
| Property | Value | Rationale for selection |
|---|---|---|
| Ascorbic Acid | ||
| concentration | 40 mg/dL (min) | Chosen so as to strongly saturate ascorbic acid |
| pads on iChem 10 SG and vChem strips . | ||
| pH | 5.0 (ref) | Same as CB control |
| Specific gravity | 1.035 (ref) | Same as CB control |
| Base matrix | Identical to CB buffer | Chosen so that CB could be the negative for CC |
| for ascorbic acid |
Matrix Effects
Comparison testing was performed on three lots of the proposed CC control compared to human negative urine spiked with ascorbic acid at 40 mg/dL. Testing was performed in triplicate on the iChem 100 Urine Chemistry Analyzer. No measurement differences were observed.
Stability
Closed vial
Closed vial stability of proposed CC controls was verified in real time on samples from three lots stored at 2-8°C, compared to reference samples stored at -20°C. The semi-quantitative variable used as a measure of stability was concentration as measured by an iChem 100 Urine Chemistry Analyzer and iChem 10SG urine chemistry strips. The criterion for meeting the stability claim was no more than one grade change in concentration over a six month period
Samples were tested at the following time points: 1 months, 3 months, 4 months, 6 months, and 7 months. These vials were compared to vials that were stored at -20C.
All vials tested had recoveries of 40mg/dL ascorbic acid for all three lots of IRISpec™CC controls after 7 months of real time stability. This study is ongoing for internal studies only since this surpasses the 6 month shelf life claim.
All negative controls (IRISpec™CA and IRISpec™ CB) tested NEG for ascorbic acid after 7 months of real time stability. This study is ongoing. However, this also passes the 6 month shelf life claim.
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Accelerated Temperature Stability Studies
Triplicate samples of all three lots of the IRISpec™CC controls were stored at accelerated temperatures of 25° C for 20 days, 16 days, 10 days and 3 days. Triplicate samples of all three lots of IRISpec™CC controls were stored at accelerated temperatures of 35° C for 7 days, 6 days, 3 days, and 1 day. These were then compared to the triplicate samples of all three lots that were stored at 2-8° C (reference samples). All samples provided ascorbic acid values of 40 mg/dL during the entire length of the study at each temperature
Additionally, triplicate samples for all three IRISpec™ CC lots and IRISpec™ CA and IRISpec ™CB were incubated at 25°C for 6 months. These were also tested and compared to IRISpec™CC lots that were stored at 2-8° C. All IRISpec™ CC samples provided ascorbic acid values of 40mg/dL. All IRISpec™CA and CB controls were NEG for ascorbic acid, as expected.
"Surrogate" QC Material
"Surroqate" QC material effects are not applicable in the case of the part C control, because the QC material in the control is identical to the analyte it is intended to monitor.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2007
Iris Diagnostics, a Division of IRIS International Inc c/o Mr. Gerald J. Haddock P.E. RAC, Director, Ouality Assurance and Regulatory Affairs 9172 Eton Avenue Chatsworth, CA 91311
K072640 Re:
Trade Name: IRISpecTM CA/CB/CC Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJW Dated: October 20, 2007 Received: October 22, 2007
Dear Mr. Haddock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K072640
Device Name: IRISpec™ CA/CB/CC
Indication For Use:
IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benam
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072640